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Results for usfda. Search took 0.28 seconds.
Seen that? - Generic Allegra from Mylan Laboratories
in Allergies, on October 16, 2009
... Mylan Pharma's Generic Glipizide and Metformin Hydrochloride Tablets, Approved by the USFDA at Daily Diabetic Mylan Pharmaceuticals' gene...
FDA Approves Akorn's Generic Ketotifen Fumarate Ophthalmic Solution, 0.025%
in Allergies, on July 29, 2007
... The USFDA has recently approved the OTC use of Akorn 's Ketotifen Fumarate Ophthalmic Solution, 0.025% - the generic version of Novartis ' Zaditor™Ophthalmic Solution 0.025% .
Zad...
Neupro® (rotigotine transdermal system): First FDA-Approved Parkinson's Disease Patch
in Straightfromthedoc, on May 10, 2007
... The first patch for Parkinson's disease has recently been approved by the USFDA: Neupro® (rotigotine transdermal system) .
A product of Schwarz Bioscience (U.S. subsidiary of Schwarz Pharma ...
New Prefilled Disposable Insulin Pen for LANTUS®: Lantus SoloStar®, FDA-Approved
in Daily Diabetic, on May 1, 2007
...hour insulin, treatment of hyperglycemia in people with type 1 or type 2 diabetes.
Now the USFDA has approved Sanofi-aventis' new prefilled disposable insulin pen specifically for use in t...
ADHD Children Who Start on Strattera® More Likely to Change Therapies, Study Says
in Straightfromthedoc, on April 19, 2007
...orepinephrine reuptake inhibitor, is the first and only non-stimulant medication approved by the USFDA for the treatment of ADHD in children, adolescents, and adults.
Find more details from the ful...
Mylan Pharma's Generic Glipizide and Metformin Hydrochloride Tablets, Approved by the USFDA
in Daily Diabetic, on April 18, 2007
...rs Squibb 's Metaglip™ Tablets .
Thanks to Mylan Pharmaceuticals, Metaglip™ now has a USFDA-approved generic counterpart.
Source: Mylan Laboratories, Inc. ...
On Ear Infections in Children and Pneumococcal Conjugate Vaccine (PCV7)
in Straightfromthedoc, on April 12, 2007
...lped reduce the number of infants and toddlers developing frequent ear infections.
Licensed by the USFDA in 2000, the PCV7 vaccine has been recommended by The Centers for Disease Control and Prevent...
Non-invasive Glucose Monitor, Under Works at Freedom Meditech
in Daily Diabetic, on March 28, 2007
...nd to glucose levels.
This device is currently under development at Freedom Meditech, working on a USFDA application and if the company secured enough finances, the device will be in the market in th...
USFDA Approved GlaxoSmithKline's Breast Cancer Drug TYKERB®
in Straightfromthedoc, on March 15, 2007
... The USFDA has recently approved TYKERB® (lapatinib) , in combination with Xeloda® (capecitabine), for the treatment of patients with advanced or metastatic breast cancer whose tumors over...
Hepatitis B Infection Drug Entecavir (Baraclude®) Builds HIV Drug Resistance
in Straightfromthedoc, on March 8, 2007
...tates that is has no clinical effects on HIV.
Authors of the said study have already informed the USFDA of their findings so that prescribing physicians will be notified and that the product's l...
CollaRx® BUPIVACAINE IMPLANT for the Management of Post-operative Pain
in The Biotech Weblog, on March 5, 2007
...ry.
Innocoll, Inc. has just recently filed an Investigational New Drug (IND) application to the USFDA for CollaRx® BUPIVACAINE IMPLANT.
Read the full press release .
...
FDA Approves First Medication for Dog Vomiting
in The Biotech Weblog, on March 3, 2007
...sing to both dog and owner but also could be a sign of a serious underlying problem.
Recently, the USFDA has approved the first medication for dog vomiting: Cerenia™ (maropitant citrate) , a product...
GSK's Fluticasone Furoate Nasal Spray Against Allergic Rhinitis
in Allergies, on March 1, 2007
...ing a range of nasal allergy symptoms: congestion, sneezing, itchy and runny nose.
Currently under USFDA review for treatment of the symptoms of seasonal allergic rhinitis (SAR) and perennial ...
Additional USFDA Indication and U. S. Patent for Veritas® Collagen Matrix, Granted to Synovis
in Straightfromthedoc, on January 14, 2007
... Synovis Life Technologies (Nasdaq: SYNO) has received USFDA clearance for an additional indication for Veritas® Collagen Matrix , an implantable, biomedical material that provides a scaffold i...
Wanted Smokers: Stanford Study Will Test Whether Antidepressant Patch, Emsam (selegiline) Can Help Them Kick The Habit For Good
in Straightfromthedoc, on January 11, 2007
... Somerset Pharmaceuticals and Bristol-Meyers Squibb , is an antidepressant patch approved by the USFDA in February 2006 .
However, Selegiline may also help smokers combat the cravings they feel wh...
Olympic Cool-Cap System: Novel Device That Prevents/Reduces Brain Damage in Infants, USFDA Approved
in Straightfromthedoc, on January 2, 2007
...born with moderate to severe hypoxic-ischemic encephalopathy (HIE), has just been approved by the USFDA.
HIE (hypoxic-ischemic encephalopathy) is a potentially fatal injury to the brain caused by l...
Five NIMH Research Projects to Fully Understand the Antidepressant Drugs' Link to Suicidality
in Straightfromthedoc, on December 30, 2006
... the use of SSRIs in children and adolescents has been controversial; controversial enough for the USFDA to issue a 'black box" warning on all SSRIs in 2005.
The "black box' is t...
USFDA Committee Recommends Simple DNA Tests To Patients Prior to Coumadin (Warfarin) Prescription
in Straightfromthedoc, on November 21, 2006
Coumadin ( warfarin ) , a product of Bristol-Myers Squibb , is a prescription oral anticoagulant with the following side effects: deadly bleeding reactions or recurrent stroke, thromboembolism, or other adverse clotting events and hemmorhage.
In the past, achieving the correct dose of warfar...
Use of Silicon Breast Implants, USFDA Approved after 14-Year Ban
in Straightfromthedoc, on November 19, 2006
... On November 17, the USFDA has approved the use of silicone gel breast implants manufactured by the two Californian companies: Mentor ( Silicone Gel-Filled Breast Implants ) and Allergan ...
VitalStim® Therapy, Found More Effective Than Traditional Dysphagia Treatment
in Straightfromthedoc, on November 16, 2006
...perior to traditional therapies for the treatment of dysphagia.
VitalStim® Therapy is a painless USFDA-approved therapy for dysphagia that utilizes small electrical currents to stimulate the muscles ...
Long Term Clinical Data Confirms Safety and Effectiveness of Renessa® Procedure for Female Stress Urinary Incontinence (SUI)
in Straightfromthedoc, on November 9, 2006
...time, possible complications or lack of confidence in the effectiveness of available options.
The USFDA-cleared Renessa® procedure offers women with a new non-surgical approach to the effective tre...
Uroplasty's Macroplastique® Implants: Received USFDA Pre-Market Approval
in Straightfromthedoc, on November 3, 2006
... Uroplasty, Inc. (Amex: UPI ) has already received USFDA pre-market approval (PMA) for its Macroplastique® Implants .
Uroplasty can now begin marketing Macroplastique® in the United States for ...
EliA™ CCP: New Diagnostic Test that Detects Rheumatoid Arthritis (RA) in Early Stages, Received USFDA Clearance
in Straightfromthedoc, on October 29, 2006
...omated systems for autoimmune and allergy testing.
Now, EliA™ CCP has been cleared by the USFDA for marketing, providing healthcare providers with a more accurate tool in the diagnosis of RA at an...
NIH Scientists Identified a Human Protein that Helps the Spread of Chickenpox And Shingles Virus
in Straightfromthedoc, on October 22, 2006
... type of pain called postherpetic neuralgia, which can last for months or even years.
Even if the USFDA has already licensed a a shingles vaccine for people 60 and older , some people who are the m...
Gen-Probe Received USFDA Clearance to Run Standalone APTIMA® Tests for Chlamydia and Gonorrhea on the TIGRIS® System
in Straightfromthedoc, on October 21, 2006
... The USFDA has granted marketing clearance that allows Gen-Probe Incorporated (Nasdaq: GPRO ) to run its standalone APTIMA® assays for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (...
Allegra® Oral Suspension, USFDA-approved for Treatment of Seasonal Allergy Symptoms and Chronic Idiopathic Urticaria in Pediatric Patients
in Straightfromthedoc, on October 20, 2006
...ic idiopathic urticaria in children 6 months to 11 years of age has recently been approved by the USFDA .
Allegra® Oral Suspension from Sanofi-aventis (U.S.) is a good tasting, easy-to-swallow for...
DPP-4 Inhibitor by Merck: JANUVIA™, Approved by the USFDA for Type 2 Diabetes
in Straightfromthedoc, on October 20, 2006
...hibitors, Merck's JANUVIA™(sitagliptin phosphate ) has recently been approved by the USFDA for the treatment of type 2 diabetes .
In a recommended dose of 100 mg once daily, JANUVIA™ is ...
EPOCAL's EPOC™ Blood Analysis System, Received USFDA 510(k) Approval
in Straightfromthedoc, on October 15, 2006
... Blood Analysis System - has been approved for marketing in the United States by the power of a USFDA 510(k) approval.
The EPOC™ system , a blood analyzer that rapidly performs a panel of the m...
Uroplasty's Macroplastique® for Stress Urinary Incontinence (SUI), Received USFDA Approvable Letter
in Straightfromthedoc, on September 15, 2006
... Uroplasty, Inc. (Amex: UPI ) has recently received an approvable letter from the USFDA relating to its pre-market approval (PMA) application for Macroplastique® Implants for the treatment of ...
Dental Amalgam is SAFE, Reaffirms ADA
in Straightfromthedoc, on September 9, 2006
...and effective cavity-filling material.
In a written testimony to a two-day joint panel meeting the USFDA, the ADA noted that it does not endorse the use of one dental material over another, however i...
WayPoint Biomedical's Health Essist® Marijuana & Cocaine and Multi-Drug Cup Home Drug Tests, USFDA Cleared for OTC
in Straightfromthedoc, on September 1, 2006
... WayPoint Biomedical Holdings, Inc. has been granted USFDA clearance for their two new over-the-counter (OTC) home use drug tests: the Health Essist® Marijuana & Cocaine and Multi-Drug Cup (t...
RSB Spine's InterPlate™ Vertebral Body Replacement Implant System, Granted Conditional USFDA 510(k) Approval
in Straightfromthedoc, on September 1, 2006
... innovative spinal implants, RSB Spine, LLC has been recently granted conditional approval by the USFDA for the company's 510(k) application that would permit marketing of the InterPlate™ Verte...
BioForm Medical, Inc.'s Radiesse®: Recommended for Approval by FDA Advisory Panel for Two Facial Aesthetic Applications
in Straightfromthedoc, on August 31, 2006
...ation soft tissue augmentation product) has been recommended for approval (with conditions) by the USFDA's General and Plastic Surgery Devices Advisory Panel for the following indications:
...
Thoratec and Levitronix Signed U.S. Co-Distribution Agreement for Levitronix® CentriMag® System
in Straightfromthedoc, on August 30, 2006
...tribute the Levitronix CentriMag® Blood Pumping System in the United States.
Currently having USFDA 510(k) approval in the United States for use in patients requiring short-term extracorporeal (i...
Elekta's Leksell Gamma Knife® Perfexion™ Granted USFDA 510(k) Pre-market Clearance
in Straightfromthedoc, on August 26, 2006
... Elekta (STO: EKTA B ) has recently been granted USFDA 510(k) pre-market clearance for Leksell Gamma Knife® Perfexion™ , allowing the company to market this innovative new system for stereotact...
NMT Medical, Inc.'s CardioSEAL® PFO HDE Voluntarily Withdrawn, USFDA Approval for New STARFlex® PFO IDE Study Received
in Straightfromthedoc, on August 25, 2006
...aq: NMTI ) has voluntarily withdrawn the humanitarian Device Exemption (HDE) granted by the USFDA on February 1, 2000 for its CardioSEAL® Septal Repair System for closure of patent forame...
Fifth Artificial Heart Implant Conducted by Aurora St. Luke's Cardiac Team
in Straightfromthedoc, on August 24, 2006
...dition after receiving his Cardio West temporary total artificial heart (TAH-t) implant ; the only USFDA approved temporary Total Artificial Heart.
aurora St. Luke's Medical Center is one...
Milestone Scientific's Single Tooth Anesthesia Device (STA), Granted USFDA 510(k) Premarket Notification Clearance
in Straightfromthedoc, on August 24, 2006
... anesthetic delivery systems, Milestone Scientific Inc. (Amex: MSS ), has recently received USFDA 510(k) Premarket Notification clearance for the marketing and sale of its Single Tooth Anesth...
Daptomycin: New Treatment against Dangerous S. Aureus Bacteria
in Straightfromthedoc, on August 23, 2006
...stream and heart infections caused by Staphylococcus aureus bacteria.
The said trial as basis, the USFDA has already approved daptomycin for the treatment of heart infections and bacteremia , also k...
New Diabetes Drug Combo, Duetact™: Combines Pioglitazone and Glimepiride
in Straightfromthedoc, on August 21, 2006
... The new diabetes drug combo recently approved by the USFDA called Duetact™ is a combination of two common diabetes drugs - pioglitazone (sold as Actos® ) and glimepiride (sold as Amaryl® ) - ...
Collagen Matrix, Inc.'s Collagen Nerve Wrap, Received USFDA 510(k) Clearance for Peripheral Nerve Injury Repair
in Straightfromthedoc, on August 9, 2006
...of collagen-based extracellular matrices for tissue and organ repair and regeneration, has received USFDA 510(k) clearance of its Collagen Nerve Wrap indicated for the management of peripheral nerv...
VNUS® Medical Technologies, Inc.'s ClosureFAST™ RF Catheter Received USFDA 510(k) (Marketing) Clearance
in Straightfromthedoc, on August 8, 2006
... VNUS® Medical Technologies, Inc. (Nasdaq: VNUS), has recently received 510(k) clearance from the USFDA to market its ClosureFAST™ radiofrequency catheter in the United States.
VNUS® Medical Techn...
Innovasis' 'PEEK Box' System as Vertebral Body Replacement (VBR), Submitted to the USFDA for Clearance
in Straightfromthedoc, on August 7, 2006
...sis , the Utah-based spinal implant company has submitted its "PEEK Box" System to the USFDA for 510(k) clearance.
Manufactured from PolyEtherEtherKetone (PEEK) with Tantalum ELI marker...
ADEPT® Adhesion Reduction Solution [4% Icodextrin Solution], Approved by the USFDA
in Straightfromthedoc, on August 5, 2006
...gynecological laparoscopic procedures in the United States, has been recently approved by the USFDA.
ADEPT® , a 4% icodextrin solution (been used for adhesion reduction in Europe since 2000) is...
Newly Approved Wet AMD Drug, Lucentis: May Help Fight Eye Disorder
in Straightfromthedoc, on August 2, 2006
... Lucentis (ranibizumab) has been approved by the USFDA last month. This drug is administered by injection directly into the eyeball of patients suffering from wet age-related macular degenerati...
AtriCure, Inc.'s Multifunctional Isolator™ Transpolar™ Pen System Received USFDA 510(k) Clearance and New Isolator Transpolar Open Clamp Released
in Straightfromthedoc, on July 30, 2006
... AtriCure, Inc. has received USFDA 510(k) clearance for its Isolator Transpolar Pen System (Pen) for pacing, sensing, stimulating, and recording during the evaluation of cardiac arrhythmias in a...
Oncaspar® (pegaspargase): USFDA Approved for Newly-Diagnosed Acute Lymphoblastic Leukemia (ALL)
in Straightfromthedoc, on July 27, 2006
... In 1994, Oncaspar® has been approved by the USFDA for the treatment only of acute lymphoblastic leukemia (ALL) patients who were allergic to the cancer drug L-asparaginase.
Now, the USFDA has ...
TyRx Pharma, Inc.'s PIVIT™ AB, a Novel Antimicrobial-Coated Surgical Mesh: Granted USFDA 510(k) Clearance
in Straightfromthedoc, on July 27, 2006
... TyRx Pharma, Inc. has recently been granted USFDA 510(k) clearance for PIVIT™ AB , a new surgical mesh product coated with a proprietary bioresorbable polymer containing the antimicrobial ...
Abbott's First Fully-Automated Blood Screening Tests for Hepatitis B Surface Antigen, USFDA Approved
in Straightfromthedoc, on July 26, 2006
... Abbott has recently been granted USFDA approval for its ABBOTT PRISM® hepatitis B surface antigen (HBsAg) and its PRISM® HBsAg Confirmatory test: tests that can be used by laboratory tec...
Abbott's CELL-DYN Ruby™ Hematology Instrument, Received USFDA Clearance
in Straightfromthedoc, on July 25, 2006
... Abbott recently announced that it has received 510(k) clearance from the USFDA for its automated, mid-volume hematology instrument, CELL-DYN Ruby™ .
CELL-DYN Ruby™ is an instrument that has adv...
Milestone Scientific Inc.'s CompuFlo™ Computer Controlled Infusion Pump, Received USFDA 510(k) Premarket Notification
in Straightfromthedoc, on July 24, 2006
...trolled local anesthetic delivery systems, Milestone Scientific, Inc. , has last week been granted USFDA 510(k) Premarket Notification acceptance for the marketing and sale of its CompuFlo™ Computer...
Implantable Contraceptive: Implanon™, Approved by USFDA
in Straightfromthedoc, on July 21, 2006
... The USFDA approved a type of contraceptive that would be implanted in the upper arm to prevent pregnancy for up to three years.
The device is called Implanon™ , made by Organon USA , a Roseland,...
USFDA Granted Biosite® Inc. Clearance to Add Methadone in its Triage® TOX Drug Screen
in Straightfromthedoc, on July 20, 2006
...ed provider of novel, rapid medical diagnostics, Biosite® Incorporated has recently been granted USFDA clearance to add methadone to its Triage® TOX Drug Screen .
This addition expands the Triag...
Cardeva™ for Chronic Heart Failure (CHF), Clinical Trial On-going
in Straightfromthedoc, on July 20, 2006
...Inc. 's long-acting form of b-type natriuretic peptide (BNP) which last week has been granted USFDA approval to commence clinical trial in the United States.
Cardeva™ (a human serum albumin (H...
PuriCore's VASHE™ Wound Cleansing System Granted USFDA 510k Approval
in Straightfromthedoc, on July 15, 2006
... hypochlorous acid. Last week, the company announced that it has received 510(k) clearance from the USFDA to market its proprietary VASHE™ Wound Cleansing System as a medical device.
The VASHE™ Sy...
TopSpin Medical's Intravascular MRI (IVMRI) Catheter Technology, USFDA Approved for Clinical Trials
in Straightfromthedoc, on July 14, 2006
... Last week, TopSpin Medical received USFDA approval to start U.S. clinical trials of its IntraVascular MRI ( IVMRI ) catheter which is intended for the characterization of lipid-rich lesions i...
Renal Soultions, Inc.'s Allient® Sorbent Hemodialysis System, Granted 510(k) Clearance by the USFDA for Chronic and Acute Hemodialysis
in Straightfromthedoc, on June 29, 2006
... Renal Solutions, Inc. recently announced that the USFDA recently granted 510(k) clearance of the Allient® Sorbent hemodialysis System , including the SORB™ series and HISORB™ series cartr...
Ascension Orthopedics' PyroCarbon Foot Implant (Ascension® PyroSphere®), Approved by USFDA
in Straightfromthedoc, on June 26, 2006
...rthopedics, Inc. , this first PyroCarbon implant for the foot recently received approval from the USFDA.
The Ascension® PyroSphere® is a revolution in TMT arthroplasty providing a new option to fo...
Smith and Nephew's VERSAJET™, USFDA Approved for Burn Indication in the U.S.
in Straightfromthedoc, on June 7, 2006
... The USFDA recently approved a label amendment of Smith and Nephew 's Advanced Wound Management Division's advanced surgical wound management product, VERSAJET™ .
VERSAJET™ has been gra...
FDA Finalized Rule of Health Claim on Barley-containing Products
in Straightfromthedoc, on May 31, 2006
...an help reduce the risk of coronary heart disease by lowering LDL and total cholesterol levels, the USFDA recently finalized a rule that allows foods containing barley to claim that they reduce the ri...
Nexa Orthopedics, Granted FDA Clearance to Market Pyrolytic Carbon Implant
in Straightfromthedoc, on May 25, 2006
...urgery of the extremities, Nexa Orthopedics, Inc. has recently received 510(k) clearance from the USFDA to market its pyrolytic carbon Carpometacarpal Implant (CMI).
"Pyrolytic carbon has b...
Intra Vas Device (IVD), New Male Contraceptive That Targets Sperms Instead of Hormones
in Straightfromthedoc, on May 12, 2006
...s," she said.
The new male contraceptive researchers very recently have been approved by the USFDA to go ahead with the 90-man study of the Intra Vas Device (IVD). IVD is a non-hormonal contr...
MiniMed's Paradigm® REAL-TIME Insulin Pump and Continuous Glucose Monitoring System, a Step towards Artificial Pancreas Technology
in Straightfromthedoc, on April 19, 2006
... The USFDA recently approved Medtronic Diabetes ' MiniMed Paradigm® REAL-TIME Insulin Pump and Continuous Glucose Monitoring System , a new technology that will allow patients take immediate...
New PCR-based Identification System for Enterovirus
in The Biotech Weblog, on April 18, 2006
...il Cepheid submitted its Xpert EV™ (Enterovirus) Assay for use on the GeneXpert® System to the USFDA for regulatory clearance. The company is seeking clearance of this assay as a laboratory test to ai...
Vagus Nerve Stimulator: Mood Machine, Too Good To Be True?
in Straightfromthedoc, on March 23, 2006
...f the brain", the vagus nerve stimulator (VNS) which has been approved eight months ago by the USFDA.
Cybetronics of Houston is the manufacturer of VNS which is being implanted in the patient...
LUMA™ Cervical Imaging System Received USDA PMA
in Straightfromthedoc, on March 17, 2006
... MediSpectra, Inc. received USFDA approval for its PMA (premarket approval) application for LUMA™ Cervical Imaging System, the first optical imaging device approved as an aid to clinicians examini...